Priority New Monograph Items

USP seeks sponsors to aid in developing the following list of monographs that are not part of the official USP-NF.  The list contains drug substance, drug product, and excipient monographs.  We may accept any qualified sponsor for a monograph estimated to make generic market entry within 5 years.  We will work exclusively with approved manufacturers on monographs expected to make generic market entry in more than 5 years.  These articles have been approved by the FDA and are published in the Approved Drug Products with Therapeutic Equivalence (Orange Book).

Consult the missing monograph list here: 
 
 
If you are interested in becoming a product sponsor, contact Michael Goede, Senior Standards Acquisition Manager, at myg@usp.org.
 

Helpful Links

For more on the monograph submission process, see USP’s Monograph Submission Guidelines.
Visit the Donor Submission Portal to register and e-file your submission.